TiGenix
ChondroCelect
Status: MAA approved in Oct. 2009
Organizations involved:
TiGenix Inc. –Manuf.; R&D; Tech.; USA mark.
Katholieke Universiteit Leuven – Tech.
University of Ghent – Tech.
Description: ChondroCelect is a formulation of autologous (patient's own) chrondocytes (cartilage-forming cells). These are extracted, cultured and re-injected as personalized therapy to repair defects in the cartilage of the femoral condyle (the end of the thighbone) in the knee.
Companies.: ChondroCelect was developed and is manufactured and marketed by TiGenix Inc., a company spun out from Katholieke Universiteit Leuven and University of Ghent.
Indications: [as reported in the EU]:
Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults. Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of ChondroCelect in patients with lesions between 1-5cm2. ChondroCelect must be administered by an appropriately qualified surgeon and is restricted to hospital use only.
Status: On Oct. 6. 2009, the European Union (EU) granted MAA approval. As part of the application, the company had to submit a risk management plan with a series of measures, including further studies, to ensure that the medicine’s efficacy and safety are followed up in a robust manner once it is on the market.
ChondroCelect was the first product to benefit from the new legal and regulatory framework for advanced therapy medicinal products (Regulation (EC) No 1394/2007) set up by EMEA/EU. In mid 2007, the MAA was filed and ChondroCelect became the first cell-based product to go for central approval at EMEA (as somatic cell therapy medicinal product). By Oct 2008, most of the outstanding questions had been resolved, with the remaing questions concerning product and process validation. On Jan 2009, the new EUAdvanced Therapy Medicinal Product regulation was implemented. In Q1 2009, answers to remaining questions were compiled for submission. EMEA recommended approval on June 25, 2009.
Tech. transfer: Tigenix has received patents including 7,485,310, "Use of CXCL6 chemokine in the prevention or repair of cartilage defects;" and 7,482,114, "In vivo assay and molecular markers for testing the phenotypic stability of cell populations, and selected cell populations for autologous transplantation."
Pending U.S. applications include 20090162328, " In vivo assay and molecular markers for testing the phenotypic stability of cell populations and selected cell populations for autologous transplantation;" 20090123927, "Isolation of Precursor Cells and Their Use for Tissue Repair;" and 20090117652, Use of CXCL6 chemokine in the prevention or repair of cartilage defects."
20090123927
Trials: In it pivotal Phase III trial, ChondroCelect was compated to the present standard-of-care surgical intervention called micro-fracture. The results were published in the Feb. 2008 issue of the American Journal of Sports Medicine and awarded the Hughston Award, given for the most outstanding paper that appeared in the AJSM the year prior to the award.
Upon EU approval, more than 500 patients had been treated. This included: a) Pivotal study: 51 ChondroCelect treated (of 118 patients); b) Military Hospital study: 20 patients; c) Expanded Access Program: 22 patients and; d) Compassionate Use/Named Patient Programs: >420 patients.
Market: Upon EU approval, the first phase of the launch of ChondroCelect focused on Germany, the Netherlands, United Kingdom and Belgium. The commercial core team is in place to support the efficient rollout of ChondroCelect in these markets, and most of the targeted orthopedic reference centers have been trained.
Tigenix has targeted 50 orthopedic centers in the EU for initial marketing.
Medical: The product is used in combination with Autologous Chondrocyte Implantation (ACI), a surgical procedure to treat cartilage defects by using the patient's own cells (i.e., this is the name of the treatment process used by TiGenix or in the EU).
Index Terms:
Companies involvement:
Full monograph
650.3 Chondrocytes, autologous/
Nomenclature:
Chondrocytes, autologous/Tigenix [BIO]
ChondroCelect [TR]
FDA Class: Biologic BLA
biopharmaceutical products
human materials used<!-- humansource -->
autologous cells, human
cartilage, femoral articular (human)
cells, human
chondrocytes, human
human cells, chondrocytes
mammalian cell culture
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM001 Marketed Product in EU
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